Tag: unapproved use

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02/24/2017

Citizen Petition Calls on FDA to Stay Final Rule Establishing “Totality of the Evidence” Standard for Intended Use

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02/20/2017

OPDP Plans Just One Guidance Document for 2017

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01/20/2017

New Memorandum Spells Out FDA’s First Amendment Position on Off-label Use Promotion

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12/15/2016

FDA Extending Unapproved Use Communications Comment Period

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11/10/2016

Speakers at FDA Off-label Hearing Call for Action that Protects Free Speech

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10/31/2016

Kamp to Urge FDA to Provide Clear Guidance on Off-label Communication at November Hearing

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09/01/2016

FDA to Hold Post-election Hearing on Off-label Communication

03/03/2014

FDA Issues Updated Draft Guidance on Distributing Scientific and Medical Info on Unapproved New Uses